Standard Operating Procedure (SOP) for Change Control

Cleaning of High Performance Liquid Chromatography (HPLC)

1. Purpose

The purpose of this Standard Operating Procedure (SOP) for Change Control is to establish a systematic process for managing and controlling changes to processes, procedures, documents, equipment, and systems within [Company Name]. This SOP for Change Control aims to ensure that changes are evaluated, implemented, and documented in a controlled and compliant manner to maintain product quality, safety, and regulatory compliance.

2. Scope

This SOP for Change Control applies to all departments and personnel involved in initiating, reviewing, approving, and implementing changes within [Company Name]. It encompasses changes to processes, procedures, documents, equipment, systems, and any other aspects that could impact product quality, safety, or regulatory compliance.

3. Definitions

3.1 Change:

Any modification, addition, deletion, or adjustment to an existing process, procedure, document, equipment, or system.

3.2 Change Request:

A formal request submitted to initiate a change, including details of the proposed change, rationale, and potential impact.

3.3 Change Control Board (CCB):

A cross-functional team responsible for reviewing, assessing, and approving change requests.

4. Change Request Initiation

5. Change Request Submission

5.1 Any employee who identifies a need for a change shall initiate a Change Request by completing the designated form.

5.2 The Change Request shall include a clear description of the proposed change, its rationale, potential impact on product quality and safety, and relevant supporting documentation.

6. Change Classification

6.1 The initiator shall classify the change request as either minor or major based on predefined criteria.

6.2 Minor changes are those that are unlikely to significantly impact product quality, safety, or compliance. Major changes have the potential to impact any of these aspects.

7. Change Evaluation and Review

8. Change Control Board (CCB)

8.1 The CCB shall review all submitted Change Requests and assess their potential impact on product quality, safety, and regulatory compliance.

8.2 The CCB shall include representatives from relevant departments, including Quality Assurance, Regulatory Affairs, and affected process owners.

9. Risk Assessment

9.1 For major changes, a risk assessment shall be conducted to evaluate potential risks associated with the proposed change.

9.2 The risk assessment shall consider factors such as severity, likelihood, and detectability of potential adverse effects.

10. Change Approval and Implementation

11. Approval Process

11.1 The CCB shall approve or reject the Change Request based on the evaluation, risk assessment, and alignment with quality and compliance standards.

11.2 Approved changes shall be documented, and implementation plans shall be developed.

12. Implementation and Documentation

12.1 The approved change shall be implemented following the established implementation plan.

12.2 All relevant documentation, including updated procedures, documents, or records, shall be updated to reflect the change.

13. Change Verification and Validation

14. Verification

14.1 After implementation, the change shall undergo verification to ensure that it was implemented correctly and as intended.

14.2 Verification activities may include testing, inspections, or other relevant checks.

15. Validation

15.1 For major changes, validation may be required to demonstrate that the change achieves its intended purpose without negatively impacting product quality, safety, or compliance.

15.2 Validation protocols and procedures shall be developed and executed as necessary.

16. Change Closure and Documentation

17. Closure

17.1 Once verification and validation activities are complete, the Change Request shall be marked as closed.

17.2 Closure shall be documented, and any necessary records shall be updated.

18. Documentation and Archiving

18.1 All change-related documentation, including Change Requests, approvals, implementation plans, and verification/validation results, shall be documented and archived for future reference and regulatory compliance.

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